- Boehringer Ingelheim (Columbus, OH)
- …of 2-3 days per week on-site.** **Duties & Responsibilities** + Independently performs batch record review and/or final disposition of drug products ... reflect Boehringer Ingelheim's high regard for our employees. The Specialist III, Batch Disposition is responsible for ensuring that batches manufactured by Contract… more
- Actalent (Hartland, WI)
- …the same individual who completed the batch record . Responsibilities + Review approximately 100 batch records per week, ensuring accuracy and ... calculations, with equations provided in the batch records . Knowledge of FDA facility document review ...identify and rectify discrepancies. Essential Skills + Experience in batch record review . + Knowledge… more
- Actalent (Hartland, WI)
- …calculations using a calculator. + Experience in quality assurance. + Proficiency in batch record review and documentation processes. Additional Skills & ... Job Title: Batch Record SpecialistJob Description We are...regulated FDA environment. + 6 months of experience with batch records review . Work Environment… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …Providing consultation or advice in alignment with QA policies + Reviewing completed records and batch sheets and working with other departments and communicate ... guidance on QA procedures and policies as well as review of documents for both internal and external transfers...Performing activities associated with disposition of product (eg document review , shipping), activities may be on the floor or… more
- Catalent Pharma Solutions (Harmans, MD)
- …records , product labels, SMPs, and product specific documents. + Independently executes batch record review for completeness, accuracy and cGMP ... and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records , master batch … more
- Catalent Pharma Solutions (Harmans, MD)
- …packaging, and release of cell and gene therapy products. + Independently executes batch record review for completeness, accuracy and cGMP compliance. ... in accordance with good documentation practices (GDP), including but not limited to: executed batch records , master batch records , product labels, SMPs,… more
- Aerotek (Chicago Heights, IL)
- …Additionally, you will perform housekeeping duties during machine operation and communicate batch records with the next shift and supervisors. This position ... **Responsibilities** + Attend daily safety meetings. + Receive and review batch sheets. + Formulate chemicals according...Perform housekeeping duties while machines are running. + Communicate batch records with the next shift and… more
- West Pharmaceutical Services (Kinston, NC)
- Quality Specialist, Batch Record Requisition ID: 69645 Date:...review and approve of samples and / or batch release including review and approval of ... **Job Summary** In this role you will be responsible to independently provide analytical review of the data generated for internal and external customers as well as… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …individual acts as the primary liaison to our customer's quality assurance groups for batch record review and release. The position requires communication ... The position requires the individual to prepare customer files, review and approve batch records ,...clinical design layout, ensuring blinding techniques are followed. + Review of completed batch record … more
- Kelly Services (Barceloneta, PR)
- …Engineering, IS and Administration personnel. The batch record review encompasses manufactured batch records , investigation of deviations, exceptions ... Administration personnel. The batch record review encompasses manufactured batch records , investigation of deviations, exceptions and nonconformance… more
- Mallinckrodt Pharmaceuticals (Raleigh, NC)
- …Daily Notification to Management. They provide support for customer inquiries, gap assessments, batch record review , and label preparation as assigned. ... including but not limited to the following: Annual Product Review , Management Review , Audits, Product Complaints, CAPA,... records to including but not limited to, batch record scanning, documentation error tracking and… more
- Catalent Pharma Solutions (Harmans, MD)
- …as routine production tasks. + Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records , SOP's, ... manufacturing and support area of manufacturing using SOP's and batch records . Operating production equipment for upstream...Ensure batches adhere to established Quality standards. + GMP batch review and close-out with Quality Assurance… more
- Curia (Albuquerque, NM)
- …primary quality assurance contact for CURIA-Albuquerque clients + Responsible for ensuring batch records have been thoroughly reviewed before product disposition ... improvement initiatives + Will provide quality training related to batch review , sitewide + Read/interpret SOPs to...pressure to meet customer and business deadlines associated with batch record lot release Other Qualifications: +… more
- PCI Pharma Services (Rockford, IL)
- …to ensure compliance standards are met and maintained. Facilitates customer questions for Batch Record review and Documentation Updates. Maintains a positive ... organizing internal and customer approval of batch records and specifications. + Assist with performing record...information. + Assist in the preparation of annual product review data. + Assist with generating and presenting quality-related… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is ... adhered to. Job Description ESSENTIAL FUNCTIONS : + Execute batch record review and document...complex calculations and formulas + Ability to focus and review batch records for an… more
- Zimmer Biomet (Norfolk, VA)
- …recognised. **What You Can Expect** The Document Control Coordinator responsibilities include batch record review and release, documentation processing and ... for medical devices. **How You'll Create Impact** Responsible for review of batch records , creating...for accuracy, completeness and cGMP + Documentation Control / Record Management + Configures and implements document change orders… more
- Novo Nordisk (Bloomington, IN)
- …to solve issues presented in BRs during Analyst review + Assists QA Batch Record Review with Client Observations, including priority observations from QA ... of all types of GMP Documentation including Master Batch Records , Engineering Studies, Logbooks, Forms, etc....specific area for the purpose of material readiness, and record review + Assists supply chain in… more
- Catalent Pharma Solutions (San Diego, CA)
- …cGMP (Good Manufacturing Practices) regulations + Liaison between Manufacturing and QA for executed Batch Record Review and flow of documents + Liaison ... between QA and client and effectively communicates with clients in regards to Executed Batch Records (EBR) and review status + Tracks status of Executed … more
- PCI Pharma Services (Philadelphia, PA)
- …in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record review during batch processing in ... process equipment are within required specifications. + Performs in-line review of batch record (MPI)...within acceptable job parameters. + Proactively identify gaps in batch records to mitigate deviations and documentation… more
- Nitto Denko Corp. (Milford, MA)
- …the manufacturing process and operations. This includes leading and managing multiple QA teams for batch record review , batch disposition, and on the ... guidance to the QA team supporting GMP manufacturing activities, batch record review , and ...approve GMP documents, including deviation, change control, CAPA reports, batch records , SOPs, and material specifications, and… more